The MHRA consultation on medical device regulation is here. What next?

Now that The Medicines and Medical Devices Act has become legislation the Medicines and Healthcare products Regulatory Agency (MHRA) will issue new regulations as to the requirements of the future of unique device identification and identification of medical device actors in Great Britain (GB). One of the regulations for the MHRA will be to register medical devices to create a database of devices on the GB (England, Scotland and Wales) market.

Timelines for the regulation to register medical devices are as follows:

• Class III 1 May 2021
• Class IIa and IIb 1 Sept 2021
• Class I 1 January 2022  

The registration will ensure a unique device identifier (UDI) for each medical device and the MHRA are currently reviewing options for the identification of license holders.

The MHRA has now released (on 16 September) a public consultation addressing the future of UDI regulation in the UK. The consultation will call for the opinions of medical device manufacturers, wholesalers, distributors, suppliers, healthcare provider organisations, and solution providers, to share input.

For the fundamentals of UDI to work efficiently, there needs to be no ambiguity as to what the product’s primary identifier is. A sole, globally unique identifier should be used on the designated device – one barcode standard only, encompassing all the necessary product information i.e. batch/lot number and expiry date.

Organisations (in this case those listed above) should also be accurately identified by a single means that is universally recognised – a standard identifier for the economic operator. This will improve the traceability of products to ensure compliance with regulation as a critical patient safety measure.

This is a unique opportunity for all healthcare stakeholders to help shape the future of UDI regulation in the UK.

Here are the two easy steps you need to follow to do so:

1. One nominated respondent needs to be allocated from your organisation to address the public consultation
    
2. Present your recommendations/suggestions regarding the use of a single, globally unique identifier for medical devices. One barcode standard to be used across all device packaging to prevent confusion or identification errors.

Closing date: The deadline for submissions is 11:45pm on 25 November 2021.

We have produced a handy briefing document regarding the consultation which highlights the key points relevant to you as a GS1 member or partner. You can  download the guide here.

For further information, the MHRA are holding an introductory webinar into the background of the consultation – details for this can be found below. We recommend that you join this session to find out more.

You can also have a read of our earlier article for reference here.